Particulate contamination has sparked the recalls of numerous injectable drugs over the years, with Amneal’s hospital med ropivacaine now the latest to fall victim to the trend. Amneal is recalling ...
The Food and Drug Administration has issued a stern warning to Amneal Pharmaceuticals for what it called “significant violations” of manufacturing standards, citing instances in which the drugmaker ...
Rogue particles turning up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK. Now, North Carolina-based specialty drugmaker Exela Pharma ...
As semiconductor devices become more complex and the critical particle size for today’s cutting-edge technology nodes falls into the sub-10 nm size range, controlling and mitigating potentially ...
In 2016, the FDA identified particulate matter contamination as the second leading cause of product recalls. Current contaminant detection techniques, such as light obscuration (LO), are restricted in ...
To guarantee the safety and efficacy of products manufactured in cleanroom environments, organizations such as International Organization for Standardization (ISO) and regulatory bodies such as the ...